Department of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, Entrance 95/96, Uppsala 751 85, Sweden.
Faculty of Pharmacy and Food Science, University of Barcelona, c/Joan XXIII, 27-31, Barcelona 08028, Spain.
Int J Qual Health Care. 2024 Mar 18;36(1). doi: 10.1093/intqhc/mzae020.
Biopharmaceuticals are complex biological molecules that require careful storage and handling to ensure medication integrity. In this study, a work system analysis of real-world protein drug (PD) handling was performed with the following goals: identify main barriers and facilitators for successful adherence to accepted recommendations in PD handling, analyse differences in two organizations, and define a Best Current Practice in the real-life handling of PDs based on the results of the work system analysis. Observational study was held in two university hospitals in Spain and Sweden. Based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, the tools chosen were: the PETT scan, in order to indicate the presence of barriers or facilitators for the PETT components (People, Environment, Tools, Tasks); the Tasks and tools matrices to construct a checklist to record direct observations during the real-life handling of biopharmaceuticals, and the Journey map to depict the work process. Observations were performed between March and November 2022. Each episode of direct observation included a single protein drug in some point of the supply chain and considered all the elements in the work system. Based on the results of the work system analysis and the literature review, the authors propose a list of items which could be assumed as Best Current Practice for PDs handling in hospitals. There were a total of 34 observations involving 19 PDs. Regarding People involved in the work process, there was a diversity of professionals with different previous training and knowledge, leading to an information gap. With respect to Environment, some structural and organizational differences between hospitals lead to risks related to the time exposure of PDs to room temperature and mechanical stress. Some differences also existed in the Tools and Tasks involved in the process, being especially relevant to the lack of compatibility information of PDs with new technologies, such as pneumatic tube system, robotic reconstitution, or closed-system transfer devices. Finally, 15 suggestions for best current practice are proposed. Main barriers found for compliance with accepted recommendations were related to the information gap detected in professionals involved in the handling of protein drugs, unmonitored temperature, and the lack of compatibility information of protein drugs with some new technologies. By applying a Human Factors and Systems Engineering Approach, the comparison of two European hospitals has led to a suggested list of Best Current Practices in the handling of protein drugs in a hospital.
生物制药是复杂的生物分子，需要小心储存和处理以确保药物的完整性。在这项研究中，对现实世界中蛋白质药物 (PD) 处理进行了工作系统分析，目的是：确定成功遵守 PD 处理接受建议的主要障碍和促进因素，分析两个组织之间的差异，并根据工作系统分析的结果定义 PD 实际处理中的最佳当前实践。观察性研究在西班牙和瑞典的两所大学医院进行。基于患者安全系统工程倡议 (SEIPS) 模型，选择的工具是：PETT 扫描，以指示 PETT 组件（人员、环境、工具、任务）存在的障碍或促进因素；任务和工具矩阵，以构建记录生物制药实际处理过程中直接观察结果的检查表，并绘制工作流程的旅程图。观察于 2022 年 3 月至 11 月进行。每次直接观察的事件都包括供应链中的单个蛋白质药物，并考虑了工作系统中的所有元素。根据工作系统分析和文献综述的结果，作者提出了一份清单，其中包含一些可以作为医院 PD 处理最佳当前实践的项目。共有 34 次观察，涉及 19 种 PD。在参与工作过程的人员方面，存在不同专业和不同先前培训和知识的多样性，导致信息差距。在环境方面，医院之间的一些结构和组织差异导致 PD 暴露在室温下和机械压力下的时间风险。处理过程中涉及的工具和任务也存在一些差异，特别是 PD 与新技术（如气动输送系统、机器人重组或密闭式转移装置）缺乏兼容性信息的问题尤为重要。最后，提出了 15 条最佳实践建议。发现与遵守接受的建议相关的主要障碍与处理蛋白质药物的专业人员中的信息差距、未监测的温度以及蛋白质药物与一些新技术缺乏兼容性信息有关。通过应用人为因素和系统工程方法，对两家欧洲医院的比较导致了在医院处理蛋白质药物的最佳实践建议清单。
